Diphenhydramine Hydrochloride Tablet
FDA Label NDC 76457-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Simpex Pharma Pvt. Ltd for the product Diphenhydramine Hydrochloride (NDC 76457-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, consult your doctor if you have, consult your doctor if you are taking sedatives or tranquilizers, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Tablet)

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine

Uses

temporarily relieves symptoms due to common cold, hay fever or other allergies affecting the upper respiratory tract

  • runny nose
  • sneezing
  • Itchy watery eyes
  • Itching of the nose or throat.

Warnings

Do Not Use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin.

Consult Your Doctor If You Have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland.

Consult Your Doctor If You Are Taking Sedatives Or Tranquilizers

  • sedative, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur especially in children.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Or Reach Of Children.

In case of overdose, get medical help or contact a poison control center right away.

When Using This Product

  • marked drowsiness may occur
  • avoid alcoholic drinks.

Directions:

  • take every 4 to 6 hours
  • do not take more than 6 does in 24 hours
  • Adult and children 12 years of age and over - 1 to 2 tablet
  • Children 6 to 12 years of age - 1 tablet
  • Children 6 years of age - do not use this product in children under 6 years

Other Information

  • each tablet contains: Calcium 25 mg/tablet
  • store at room temperature 15°-30° (59°-86° F)
  • protect from light and moisture

Inactive Ingredient

carnauba wax, colloidal anhydrous silica, croscarmellose sodium, dibasic calcium phosphate, hydroxy propyl methyl cellulose phthalate HP-55, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, polyvinyl alcohol, talc, titanium dioxide, xanthan gum,

Package Labeling:

Label2 (Label2)

Label2 (Label2)

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